NCT00947219

Treatment of Androgenic Alopecia in Males

A Randomized, Double-Blind, Control Device Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 & 12 Beam Models: For the Treatment of Androgenetic Alopecia in Males

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Lexington International, LLC · Industry
• Sex: Male
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.

Detailed description

This is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair). The trial will involve approximately 75 male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Norwood-Hamilton IIa to V, have active hair loss within the last 12 months. Subjects will use the device on three non-consecutive days a week as directed per device for 26 weeks treatment duration. Safety analysis will be assessed based on the reports of adverse events during study.

Conditions

• Androgenetic Alopecia
• Hair Loss
• Male Pattern Baldness

Interventions

Type	Name	Description
DEVICE	HairMax LaserComb	Device application 3 times week (non-consecutive days), for 26 weeks
DEVICE	Control device	Device is used 3 times a week on non-consecutive days

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-07-28
• Last updated: 2013-01-31
• Results posted: 2013-01-31

Locations

3 sites across 1 country: United States